(28 days)
The ICP Monitor is intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.
The CereLink ICP Monitor is indicated for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:
- Displays ICP Waveform .
- Displays Mean ICP numeric .
- Displays the historic mean pressure as a trend .
- Displays trend statistics (Pressure Time Dosage (PTD) , time above threshold, boxplot, . histogram)
- Stores 14-days' worth of mean ICP values .
- . Stores 24 hours of pressure waveform
- Can capture and store screen-shots 9
- . Can download various data to a USB device for printing or analysis
- Real-time data streaming of mean ICP and waveform via USB connection .
- Connect to external patient monitor .
The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with an CereLink ICP extension cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor (cleared via K173192). The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (cleared via K183406); the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables (cleared via K152670).
Let's break down the information provided to answer your request.
Based on the provided document, the CereLink ICP Monitor is a device that interfaces with pressure transducers and monitors intracranial pressure. The submission to the FDA (K210993) is for modifications to an existing CereLink ICP Monitor (predicate K183406), not for a brand new device. Therefore, the "study" described is primarily focused on demonstrating that the modifications do not negatively impact the device's safety and effectiveness compared to the original, already cleared device.
Here's the breakdown of acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for modifications to an already cleared device, the "acceptance criteria" are implied to be the successful demonstration that the modifications do not introduce new safety or effectiveness concerns and that the device continues to perform as intended and substantially equivalent to its predicate. The document doesn't list specific quantitative acceptance criteria for clinical performance in the way one might expect for a novel diagnostic algorithm. Instead, it focuses on various engineering and design-related tests to confirm the changes are benign or improvements.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Conclusion) |
|---|---|
| Performance Testing (e.g., ICP accuracy) | Pass |
| Software Integrity and Functionality | Pass |
| Electrical Safety | Pass |
| Electromagnetic Compatibility | Pass |
| Sterilization/Cleaning Requirements | Non-sterile, no change to parameters |
| Shelf-Life | Not applicable (reusable, no expiry) |
| Biocompatibility | Not applicable (non-patient contacting) |
| No new questions of safety and effectiveness | Concluded as substantially equivalent |
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a device like the CereLink ICP Monitor, which is a physiological measurement and monitoring device, the "test set" and "ground truth" are interpreted differently than for, say, an AI-powered diagnostic imaging tool.
- Test Set/Sample Size: The document refers to various bench tests including "ICP Drift Test," "Common Mode Noise and Leakage Current Power Supply Test," "13 Day Simulated Environment Validation Test," etc. These are engineering validation tests, not clinical studies with patient data in the traditional sense of a "test set." The sample sizes would refer to the number of devices or components tested, but this specific detail is not provided in a summarized form.
- Data Provenance: Not applicable in the context of clinical data for performance validation. The testing seems to be internal engineering verification and validation.
- Experts/Ground Truth/Adjudication Method/MRMC/Standalone Performance: These concepts are largely not applicable here. The CereLink ICP Monitor is not an AI-driven diagnostic device that relies on expert interpretation or establishing a ground truth for diagnostic accuracy (like identifying a lesion on an image). It's a device that measures and displays physiological parameters. The "ground truth" in this context would be the actual physical/electrical properties that the device is designed to measure and the expected behavior under various conditions (e.g., drift, noise, safety limits). The study's focus is on validating the device's performance against these engineering and safety standards, not on its diagnostic accuracy based on expert consensus.
The document explicitly states:
- "No clinical studies were required."
- "Appropriate verification of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, software, electrical safety, and electromagnetic compatibility testing."
- "The CereLink ICP Monitor is a reusable, non-sterile device. There is no expiry date and shelf-life is not applicable for this device."
- "The CereLink ICP Monitor is non-patient contacting. Therefore, biocompatibility is not applicable for this device."
- "No animal studies were required."
This indicates that the "study" primarily consisted of bench testing and engineering verification and validation to confirm that the technical modifications (power supply, internal components, software updates, etc.) did not compromise the device's ability to accurately measure ICP, maintain electrical safety, and function reliably.
8. The sample size for the training set
9. How the ground truth for the training set was established
These questions are not applicable as the CereLink ICP Monitor is not described as an AI/machine learning device that requires a training set. The modifications described are hardware and software updates to an existing physiological monitoring device, not the development of a predictive algorithm using a "training set."
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 30, 2021
Integra LifeSciences Production Corporation Marybeth Carson Regulatory Affairs Specialist 11 Cabot Boulevard Mansfield, Massachusetts 02048
Re: K210993
Trade/Device Name: CereLink ICP Monitor Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: April 1, 2021 Received: April 2, 2021
Dear Marybeth Carson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K210993
Device Name CereLink ICP Monitor
Indications for Use (Describe)
The ICP Monitor is intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Integra CereLink ICP Monitor 510(k) Summary
| (1) Submitter Information | |
|---|---|
| Name | Integra LifeSciences Production Corporation |
| Address | 11 Cabot BoulevardMansfield, MA 02048 |
| Telephone number | (781) 971-5600 |
| Primary Contact | MaryBeth Carson |
| Date of Submission | April 1, 2021 |
| (2) Name of Device | |
| Trade or Proprietary Name | CereLink® ICP Monitor |
| Common Name | Intracranial Pressure Monitoring System |
| Classification Name | Intracranial Pressure Monitoring Device (21 CFR 882.1620) |
| Device Class | II |
| Product Code | GWM |
| Rx or OTC Designation | Rx Only |
| (3) Predicate Information | |
| Predicate Device | CereLink ICP Monitor: K183406 |
| Reference Device | Codman ICP Express: K945585 |
| (4) Device Description |
The CereLink ICP Monitor is indicated for use in the ICU or OR environment for monitoring intracranial pressure (ICP) via a solid-state sensor placed directly in parenchymal tissue or integrated into an external ventricular drainage catheter placed in the ventricle. In addition to monitoring ICP and activating alarms when the intracranial pressure is outside user-set limits, the device performs these functions:
- Displays ICP Waveform .
- Displays Mean ICP numeric .
- Displays the historic mean pressure as a trend .
- Displays trend statistics (Pressure Time Dosage (PTD) , time above threshold, boxplot, . histogram)
- Stores 14-days' worth of mean ICP values .
- . Stores 24 hours of pressure waveform
- Can capture and store screen-shots 9
- . Can download various data to a USB device for printing or analysis
- Real-time data streaming of mean ICP and waveform via USB connection .
- Connect to external patient monitor .
{4}------------------------------------------------
The CereLink ICP Monitor can be transported with the patient within the hospital to continuously record data. The monitor includes a 7" color touch screen that is compatible with the use of gloves. The monitor is provided to the user with an CereLink ICP extension cable, external power supply, and comes equipped with an internal rechargeable battery. The monitor has one output channel to transfer physiological data to a compatible Patient Monitor, as well as one input channel to receive ICP readings from the implanted CereLink ICP sensor (cleared via K173192). The implanted sensor is connected to the CereLink ICP Monitor by way of the CereLink ICP Extension Cable (cleared via K183406); the CereLink ICP Monitor connects to compatible patient monitors through the patient monitor interface cables (cleared via K152670).
There are no changes to the currently marketed CereLink ICP sensors, CereLink ICP Extension Cable, or the patient monitor interface cables due to the CereLink ICP Monitor modifications.
(5) Intended Use of Device
The ICP Monitor is intended for use as an interface between compatible strain gauge type pressure transducers and standard physiological pressure monitoring systems. The ICP Monitor is also intended for use as an independent pressure monitor for displaying the mean, systolic and diastolic values of a physiologic pressure waveform in the absence of an external patient monitor.
(6) Technological Characteristics Compared to Predicate
The CereLink ICP Monitor remains substantially equivalent to the predicate CereLink ICP Monitor. The CereLink ICP Monitor has the same intended use, indications for use, clinical utility, design principles, features, user interface and fundamental scientific technology as the predicate CereLink ICP Monitor. In comparison to the predicate, the proposed CereLink ICP Monitor includes the following modifications:
| ComponentAffected | Proposed Modification | Rationale |
|---|---|---|
| PowerSupply | External Power Supply:• Replace the current 2-pronged (pin) floating power supply for a 3-pronged power supply: this new power supply continues to be Class II but now includes a functional earth connection. The DC output cable is the same length, but now has 2 conductors surrounded by a shield | • The change to a grounded power supply is made to substantially reduce the high common mode noise that affects ICP sensor performance. The reference device, Codman ICP Express, (K945585) uses a grounded power supply. |
| connected to earth ground via achoke. | • The addition of the chokeimproves immunity toelectrical fast transients andallows the device to meetthe electromagneticcompatibility requirements. | |
| • Addition of a 330uH choke to thepower supply between earth groundand the shield. | • The addition of a secondconductor within the shieldincreases the diameter ofoutput cable whileprotecting the lines fromexternal disturbances andsignal coupling. | |
| • There is a slight increase in thepower supply cable diameter from4.5mm to 5.4mm. There is no changeon the dimensions of the brick itself. | ||
| Cord to Outlet Connection: | Power supply is providedwith a cord connection tooutlet rather than blade. Thisincreases the total length ofthe power supply from 4m to6.5m, due to the 2.5m of thecord connection. | |
| • Replace the power supply blade tooutlet connection with a power supplycord to outlet connection. | ||
| • Changes length from 4m to 6.5m | ||
| InternalModifications | Removal of 2 capacitors of analogboard | The capacitors are no longerneeded in the board design asa result of the proposedchanges |
| Addition of a resistor to the ExtensionCable input circuit | The resistor was added forgrounding, better shieldingand to reduce common modenoise | |
| • Replace DC/DC converter to one | These changes were made to | |
| • Replace and/or remove multipleisolation capacitors on digital board. | ensure 2 means of patient | |
| Replaced metal standoffs with nylon | The changes were made to | |
| spacers, washers and cup sleeves to | increase creepage and | |
| separate analog board from digital | clearance distances | |
| board | ||
| Added ferrite to battery charger circuit | Ferrite was added to reduce | |
| of the digital board. | radiated emissions for EMC | |
| requirements. | ||
| Added conductive copper tape to | The copper tape electrically | |
| electrically connect the LCD back plate | connects the LCD back plate | |
| to the grounded metal frame. | to the metal frame, thereby | |
| grounding the LCD, | ||
| providing a path to ground for | ||
| electrostatic discharges, as | ||
| part of EMC requirements. | ||
| Back | Increased size of retention mechanism | The new power supply cable |
| Housing of | used to hold power supply cable. | is slightly thicker and would |
| the CereLink | not fit in original back | |
| ICP Monitor | housing retention mechanism. | |
| Software | Software updates to correct anomalies. | The software updates were |
| Updates | made to correct anomalies | |
| observed in the field. | ||
| • Added a digital Processor watchdog. | This watchdog triggers a | |
| reboot of both the digital and | ||
| analog processors if the | ||
| monitor becomes | ||
| unresponsive for 80 seconds. | ||
| The monitor will then | ||
| continue normal operation | ||
| without user intervention. | ||
| Implemented to controlelectrical fast transienteffects. | ||
| A software check was enabled tomonitor USB Babble interruptions. | The software monitors thefrequency of babbleinterruptions due to EFTpulses; device enters failsafestate if error conditions met.Unit will reboot within 2minutes to resume normaloperation without userintervention. Implemented tocontrol electrical fasttransient effects. | |
| Packaging | Increased the size of the cartoncontaining the power supply and alteredthe foam inserts within the overallCereLink ICP Monitor unit box. | The size of the power supplycarton was increased toaccommodate the new powersupply due to the increase indiameter of the DC outputcord; the foam inserts withinthe CereLink ICP Monitorunit box were modifiedaccordingly to package thelarger power supply cartonand power supply cord. |
| Labelling | Updates made to address the changesdescribed above and FDA recognizedsymbols. | Labelling changes are theresults of changes proposedin this submission and toinclude the latest recognizedsymbols per FDA consensusstandards. |
{5}------------------------------------------------
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
Summary of Nonclinical and Clinical Testing Performed
The following performance, software, electrical safety, and electromagnetic compatibility testing has been conducted in support of the substantial equivalence determination. The testing utilized well-established methods, including test methods seen in the predicate CereLink ICP Monitor 510(k): K183406.
Results of verification and validation testing conducted on the CereLink ICP Monitor demonstrated that the proposed device performed as designed, is suitable for its intended use and is substantially equivalent to the predicate device.
| Performance Testing Results | |
|---|---|
| Test | Conclusion |
| ICP Drift Test | Pass |
| Common Mode Noise and Leakage Current Power Supply Test | Pass |
| Mean Time Between Failure Calculation Test | Pass |
| Drop Test | Pass |
| Patient Monitor Related Test | Pass |
| Patient Sensor Related Test | Pass |
| 13 Day Simulated Environment Validation Test | Pass |
| Sensor and Monitor Compatibility Testing | Pass |
| Electrical Testing | Pass |
| Software Test Results | |
|---|---|
| Test | Conclusion |
| Software Validation Fail Safe Test | Pass |
| Software Functional Test | Pass |
| Software Code Review | Pass |
| Software Unit Test | Pass |
| Software Acceptance Test | Pass |
| Label and GUI Review | Pass |
| Electrical Safety and Electromagnetic Compatibility Results | |
|---|---|
| Test | Conclusion |
| IEC 60601-1:2005 + CORR.1:2006 + CORR.2:2007 + A1:2012 | Pass |
| IEC 60601-1-6:2010 + A1:2013 | Pass |
| IEC 60601-1-8:2006 + A1:2012 | Pass |
| IEC 60601-1-2:2014 | Pass |
{9}------------------------------------------------
Sterilization/Cleaning
The CereLink ICP Monitor is provided non-sterile. There are no changes to any sterilization or cleaning parameters of the subject device.
Shelf-Life Testing
The CereLink ICP Monitor is a reusable, non-sterile device. There is no expiry date and shelf-life is not applicable for this device.
Biocompatibility Testing
The CereLink ICP Monitor is non-patient contacting. Therefore, biocompatibility is not applicable for this device.
Animal Studies
No animal studies were required. Appropriate verification of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, software, electrical safety, and electromagnetic compatibility testing.
Clinical Studies
No clinical studies were required. Appropriate verification of the subject device was achieved based on the comparison to the predicate device and from the results of the bench, software, electrical safety, and electromagnetic compatibility testing.
Conclusion
Based upon the intended use, design, operating principle, scientific technology and comparison to the predicate device, and testing performed, it is concluded that the proposed modifications to the CereLink ICP Monitor do not raise any new questions of safety and effectiveness, and is therefore. substantially equivalent to the predicate, CereLink ICP Monitor.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).